Phase 3
Completed N=311
A Study of LY2951742 (Galcanezumab) in Japanese Participants With Migraine
Source: ClinicalTrials.gov NCT02959190 ↗Enrolled (actual)
311
Serious AEs
2.3%
Results posted
Aug 2020
Primary outcomePrimary: Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 54; 56; 54; 61 participants
◆ Published Evidence
Established
32citations · ~6 / year
A long-term open-label safety study of galcanezumab in Japanese patients with migraine.
Summary
The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as Galcanezumab in Japanese participants with migraine.
Linked Publications (2)
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A long-term open-label safety study of galcanezumab in Japanese patients with migraine.
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Clinical Evaluation After Discontinuation of Galcanezumab in Japanese Patients with Episodic and Chronic Migraine: Analysis of a Randomized, Placebo-Controlled Trial and Open-label Extension Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
54; 56; 54; 61; 31; 29 | — |
| SECONDARY Pharmacokinetics (PK): Serum Concentration of Galcanezumab |
21100; 46000; 21000; 42200; 20100; 39600 | — |
| SECONDARY Pharmacodynamics (PD): Plasma Concentration of Total Calcitonin Gene-Related Peptide (CGRP) |
4.51; 5.87; 4.69; 5.59; 4.37; 5.19 | — |
| SECONDARY Percentage of Participants Developing Anti-Drug Antibodies (ADA) |
12.07; 9.68; 16.13; 10.94; 12.50; 18.18 | — |
| SECONDARY Mean Change From Baseline in the Number of Migraine Headache Days (MHDs) |
-1.82; -1.49; -4.29; -3.23; -9.44; -8.97 | — |
| SECONDARY Mean Change From Baseline in the Number of Headache Days (HDs) |
-2.37; -1.75; -5.04; -4.00; -9.30; -9.42 | — |
| SECONDARY Percentage of Participants With Meeting Criteria for Reductions From Baseline Greater Than or Equal to (≥) 50% in Number of Migraine Headache Days |
48.9; 45.7; 52.7; 46.4; 35.7; 51.9 | — |
| SECONDARY Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache |
-1.40; -1.00; -3.87; -3.01; -8.36; -7.43 | — |
| SECONDARY Mean Change From Baseline in the Number of Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine Headache or Headache |
-1.62; -1.17; -4.47; -3.43; -8.21; -7.48 | — |
| SECONDARY Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score |
-0.29; -0.04; -0.02; 0.11; -0.07; -0.81 | — |
| SECONDARY Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score |
-0.38; -0.42; -8.67; -4.60; -20.71; -15.48 | — |
| SECONDARY Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 |
1.02; 0.38; 7.51; 4.56; 19.23; 18.31 | — |
| SECONDARY Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) |
80.4; 73.6; 72.4; 73.7; 82.1; 74.1 | — |
Eligibility Criteria
Inclusion Criteria
- For Episodic Migraine participants: Participants who completed the treatment period of Galcanezumab study CGAN.
- Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.
Exclusion Criteria
- For Chronic Migraine participants:
- Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
- Current use or prior exposure to Galcanezumab or other antibodies of calcitonin gene-related peptide (CGRP) or its receptor.
- Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab and the excipients in the investigational product.
- History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
- Failure to respond to 3 or more adequately dosed migraine preventive treatments from different classes (that is, maximum tolerated dose for at least 2 months).
Data sourced from ClinicalTrials.gov (NCT02959190) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.